Sepsis News and Research

Latest Sepsis News and Research

FOLOTYN available for commercial sale in the United States

Allos Therapeutics, Inc. today announced that FOLOTYN (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009. This indication is based on overall response rate.

6 Oct 2009

FDA approves Bayer's IUD Mirena for treating heavy menstrual bleeding

The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.

3 Oct 2009

Acute therapy and follow-up care of burn disease discussed

Almost three quarters of patients with extensive burns die of the consequences of a severe infection. In the current edition of Deutsches Ärzteblatt International, Timo A. Spanholtz of the Cologne-Merheim Burn Center and his coauthors discuss the acute therapy and follow-up care of burn disease.

1 Oct 2009

Safety profiles of JANUVIA and JANUMET drugs established through clinical development program

Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients.

28 Sep 2009

FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 2009

Morphotek announces preliminary data from Phase II trial of farletuzumab

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, today announced preliminary data from a Phase II trial evaluating the safety and efficacy of farletuzumab in platinum-sensitive epithelial ovarian cancer subjects experiencing their first relapse. Farletuzumab (MORAb-003) is a humanized monoclonal antibody that targets the Folate Receptor Alpha (FRA).

26 Sep 2009

European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes.

26 Sep 2009

Merck, QIAGEN to collaborate to increase access to HPV vaccination and HPV DNA testing in developing countries

Merck & Co., Inc. and QIAGEN N.V. today announced their intent to collaborate on a new program to increase access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world.

From QIAGEN Manchester Limited 24 Sep 2009

Results of Phase 3 CRYSTAL study of mCRC patients announced

The retrospective CRYSTAL analysis was conducted as a result of an effort to increase the tissue ascertainment rate to determine the K-ras status of patients’ tumors. The analysis included extended patient follow up of nearly 1.5 years and doubled the tissue ascertainment rate from 45% to 89%. These data are an update from the overall survival results from CRYSTAL that were published in the April 2009 issue of the New England Journal of Medicine.

23 Sep 2009

Amgen announces Phase 3 results evaluating Vectibix in combination with FOLFIRI chemotherapy

Amgen (Nasdaq: AMGN) today announced detailed results from the Phase 3 '181' trial evaluating Vectibix((R)) (panitumumab) in combination with FOLFIRI (an irinotecan based chemotherapy), as a second-line treatment for metastatic colorectal cancer (mCRC). In this trial, Vectibix significantly improved progression-free survival (PFS) in patients with KRAS wild-type mCRC.

22 Sep 2009

Amgen to present its four Phase 3 clinical trial results

Amgen today announced it will present detailed data from four Phase 3 studies as well as other data at the ECCO 15 - ESMO 34 European Multidisciplinary Congress, September 20 - 24, 2009 in Berlin, Germany.

16 Sep 2009

Clinical study results of DAS181 against H1N1 influenza presented

NexBio, Inc. announced today the presentation of two studies of DAS181 activity against H1N1 influenza and NAI-resistant influenza at the 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting on Sunday, September 13, 2009, in San Francisco, CA.

14 Sep 2009

FAB Pharma to develop new class of anti-MRSA drugs

FAB Pharma today announced the completion of a €2.3 million round of series A funding led by CDC innovation and co-led by Bioam Gestion.

14 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Therapeutic principles of monoclonal antibodies

Professor Joachim R. Kalden, Member of the Department for Molecular Immunology, Nikolaus-Fiebiger-Zentrum, University Medical School Erlangen-Nuremberg, presents therapeutic principles based on monoclonal antibodies.

10 Sep 2009

Merck's GARDASIL receives approval from FDA Advisory Committee

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

10 Sep 2009

Thermo Fisher Scientific to acquire B.R.A.H.M.S. for $470 million

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, has signed a definitive agreement to acquire B.R.A.H.M.S. AG for €330 million (approximately $470 million USD). B.R.A.H.M.S. is a leading provider of specialty in-vitro diagnostic tests based on its patented biomarkers for sepsis, cardiovascular and pulmonary diseases, as well as intensive care treatments and prenatal screening.

From Thermo Fisher Scientific Inc. 3 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

Pathogenic microbes can suppress immune system in newborns

Group B Streptococcus (GBS), a bacterial pathogen that causes sepsis and meningitis in newborn infants, is able to shut down immune cell function in order to promote its own survival, according to researchers at the University of California, San Diego School of Medicine and the Skaggs School of Pharmacy and Pharmaceutical Sciences.

2 Sep 2009

Cimzia approved for treating adult patients with rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1 Sep 2009